Oftentimes in the medical treatment of patients, it becomes necessary to intravenously or otherwise infuse a fluid into the body of the patient over a protracted period of time. Normally under such circumstances, a tube or catheter is secured within the particular body portion of the patient and the desired fluid is then arranged to flow through the catheter or tube via an intermediate connector unit, such that the catheter or tube can remain in place during periods of disconnection. Additional fluid supply or different fluid supply can thereafter be operatively connected thereto as desired. Obviously in those situations where it becomes necessary to disconnect the fluid supply or reinstitute fluid flow through the tube or catheter, care must be taken to avoid contamination of the patient. It is thus necessary to maintain sterile conditions, such that, bacteria are not introduced into the patient's body that could lead to infection. While obviously contamination could occur by removal of a sterile connector from its package, the present concern and context of sterility is that the unit not have been previously used unless it has been resterilized following such use.
Reconnection of a fluid supply to a tube, catheter or the like via a reuseable connector unit, is accomplished only after the connector is physically cleaned with special solutions such that any bacteria present are supposedly killed. In general, the physical cleaning operation is particularly tedious and time consuming without any guarantee that the connector is in fact sterile after cleaning. Should the connector not be sterile after cleaning, during reuse of same, the patient could become infected. In fact, in certain instances the connector unit is manipulated by patients or others in home bound situations. Resterilization of the connector units is distasteful to these persons to the point that without proper supervision, there is a tendency to cut corners, usually resulting in some degree of patient infection.
In order to reduce the problems incident to resterilization of reuseable connectors, the medical industry has generally moved from the reuseable connector to disposable, presterilized connectors which have gained considerable acceptance. When, however, repeated interruption of the fluid connection is necessary, such as with peritoneal dialysis, the act of inserting the presterilized, disposable connector can generate the same general problems as resterilization of a previously used component, in that the disposable unit could be reused, or attempts made to resterilize same for further use.
Clearly with any type of connector there must be replacement at some interval and at such times, sterile procedures should always be utilized. For example, in a situation where a patient must connect daily, such as a patient requiring peritoneal dialysis, utilizing state of art connectors, the patient undergoes 14 exposures per week, one per connection and one per disconnection where a non-sterile connector could be inadvertently or otherwise reused.
The present device, while not alleviating totally the need for sterile procedure clearly can be utilized to reduce same to a minimal amount. For example, utilizing a device according to teachings of the present inventon, the patient requiring peritoneal dialysis could be exposed to only two situations per week where conventional sterile procedures must be utilized, one when the old unit is disconnected and the other when a new multiple sterile connector unit is connected thereto. Such would affect a reduction of potential for infection from 14 instances to 2 instances, or approximately an 85% reduction in potential bacterial infection due to non-sterile connector conditions. Similar situations exist for chemotherapy, hyperalimentation, and other similar procedures.
In essence therefore, the present invention eliminates the problem of resterilization, and, in essence, provides a series of disposable, presterilized, interrelated connectors which are constantly ready for use. The subject matter of the present invention is neither taught nor suggested by any known prior art.